A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma

Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision-making about new drugs to treat multiple myeloma (MM). MM assessments have been based on endpo...

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Detalhes bibliográficos
Publicado no:Clin Pharmacol Ther
Main Authors: Raju, G.K., Gurumurthi, Karthik, Domike, Reuben, Kazandjian, Dickran, Landgren, Ola, Blumenthal, Gideon M., Farrell, Ann, Pazdur, Richard, Woodcock, Janet
Formato: Artigo
Idioma:Inglês
Publicado em: 2017
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Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7418461/
https://ncbi.nlm.nih.gov/pubmed/28901535
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.871
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